Oliner Kelly S, Shiller Michelle, Schmid Peter, Ratcliffe Marianne J, Schetter Aaron J, Tsao Ming-Sound
Precision Medicine and Biosamples, Oncology R&D, AstraZeneca, Gaithersburg, Maryland.
Baylor University Medical Center, Dallas, Texas.
Clin Cancer Res. 2025 Mar 3;31(5):795-800. doi: 10.1158/1078-0432.CCR-24-2729.
A companion diagnostic is a diagnostic test that provides information essential for the safe and effective use of a corresponding therapeutic product. To obtain marketing approval, the companion diagnostic must demonstrate acceptable analytical and clinical performance. Companion diagnostic regulations are intended to protect patients by ensuring quality and consistency of treatment-guiding biomarker testing in clinical trials and clinical practice. However, current regulations have had unintended negative consequences relating to innovation, implementation, and accessibility of precision medicine; increasing complexity and cost burden; and inhibiting development of novel diagnostics and biomarker-targeted therapeutics. We propose a range of practical solutions to these challenges, advocating that regulators, pharmaceutical companies, molecular pathologist groups, and diagnostic companies work together to increase flexibility and promote diagnostic innovation, while maintaining high-quality diagnostic testing to ensure all patients get the most appropriate treatments.
伴随诊断是一种诊断测试，可为安全有效地使用相应治疗产品提供至关重要的信息。为获得上市批准，伴随诊断必须证明具有可接受的分析和临床性能。伴随诊断法规旨在通过确保临床试验和临床实践中治疗指导生物标志物检测的质量和一致性来保护患者。然而，现行法规在精准医学的创新、实施和可及性方面产生了意想不到的负面后果；增加了复杂性和成本负担；并抑制了新型诊断方法和生物标志物靶向治疗药物的开发。我们针对这些挑战提出了一系列切实可行的解决方案，主张监管机构、制药公司、分子病理学家团体和诊断公司共同努力，提高灵活性并促进诊断创新，同时保持高质量的诊断测试，以确保所有患者都能得到最恰当的治疗。
